Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds (PPСPGM-EW)

82.1% of patients with gunshot and mine-explosive wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Identifying predictors of pain chronicity in these patients may improve their treatment outcomes.

Study Overview

• Status: Completed
• Conditions: Chronic Pain, Widespread
• Intervention / Treatment: Other: visual analog scale

Detailed Description

The study of predictors of pain chronicity in patients with gunshot and mine-explosive wounds requires in-depth study, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions have their own characteristics. Since pain becomes chronic in 82.1%, the data of our study will play an important role in preventing the chronicity of pain.

• Study Type: Observational
• Enrollment (Actual): 2215

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Bogomolets National Medical University, Ministry of Health of Ukraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations.

A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.

Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv.

Description

Inclusion Criteria:

• the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

• absence of gunshot and mine-explosive injuries

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
prospective study; Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv. All patients with gunshot wounds were evacuated to the stage of treatment - the National Military Medical Clinical Center "Main Military Clinical Hospital". The research was conducted using the same methods as during the retrospective analysis. The exception was the study period during treatment at the military medical clinical center: here it was 14 days.	Other: visual analog scale; In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale.; Other Names: Chaban Quality of Life Scale; Mississippi scale of post-traumatic stress disorders (military version) (MS PTSD (m)); neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4).; The Hospital Anxiety and Depression Scale
retrospective analysis; A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury. In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction scale The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale.	Other: visual analog scale; In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale.; Other Names: Chaban Quality of Life Scale; Mississippi scale of post-traumatic stress disorders (military version) (MS PTSD (m)); neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4).; The Hospital Anxiety and Depression Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	evaluation of the number of points	1 year
Didier Bouhassiraa DN4	evaluation of the number of points	1 year
The Hospital Anxiety and Depression Scale	evaluation of the number of points	1 year
Chaban Quality of Life Scale	evaluation of the number of points	1 year
Mississippi PTSD scale (military version)	evaluation of the number of points	1 year

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): May 24, 2022
• Study Completion (Actual): May 24, 2022

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Chronic pain, gunshot wounds, mine-explosive wounds
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: №158, 2022.23.05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No